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1752 News Found

Fitch revises outlook on Jubilant Pharma to negative; affirms at 'BB'
News | February 19, 2022

Fitch revises outlook on Jubilant Pharma to negative; affirms at 'BB'

Fitch estimates JPL's EBITDA to drop significantly in FY23 due to lower volume and narrowing of the margin to 11% (FY22 estimate: 14%).


Amneal expands injectables portfolio with four new products
Drug Approval | February 19, 2022

Amneal expands injectables portfolio with four new products

Launching Dexamethasone, Azacitidine, Carboprost, and Atropine for the Institutional Market


Covid-19 fuels innovative PCR-based detection methods
Medical Device | February 19, 2022

Covid-19 fuels innovative PCR-based detection methods

According to Fortune Business Insights, the launch of new PCR-based detection techniques will lead to a surge in demand for PCR instruments in the coming years


Arrowhead Pharmaceuticals initiates study of ARO-C3
News | February 19, 2022

Arrowhead Pharmaceuticals initiates study of ARO-C3

AROC3-1001 is a phase 1/2, placebo controlled, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARO-C3


USFDA accepts Mirati Therapeutics' New Drug Application for Adagrasib
Drug Approval | February 18, 2022

USFDA accepts Mirati Therapeutics' New Drug Application for Adagrasib

The Prescription Drug User Fee Action (PDUFA) date for adagrasib is December 14, 2022


USFDA clears Kairos Pharma’s IND to treat prostrate cancer
Biotech | February 18, 2022

USFDA clears Kairos Pharma’s IND to treat prostrate cancer

Phase 2 clinical trial to begin in 2022 with participation by Cedars Sinai Medical Center, University of Utah, and City of Hope


Bayer raises peak sales for Nubeqa to exceed €3 billion
News | February 18, 2022

Bayer raises peak sales for Nubeqa to exceed €3 billion

Darolutamide is developed jointly by Bayer and Orion Corporation


Center for Breakthrough Medicines launches analytical testing
Biotech | February 17, 2022

Center for Breakthrough Medicines launches analytical testing

More than 2,500 submissions are currently under review in the Food and Drug Administration's (FDA) cell and gene therapy pipeline


USFDA accepts for Priority Review Bristol Myers Squibb’s Supplemental BLA for Breyanzi
Biotech | February 17, 2022

USFDA accepts for Priority Review Bristol Myers Squibb’s Supplemental BLA for Breyanzi

Application based on the pivotal Phase 3 TRANSFORM study in which Breyanzi showed significant and clinically meaningful improvements over salvage chemotherapy followed by high-dose chemotherapy plus autologous stem cell transplant, which has been the standard of care for more than 20 years


Swissmedic  approves BeiGene's Brukinsa
Drug Approval | February 17, 2022

Swissmedic approves BeiGene's Brukinsa

With this approval, Brukinsa is now approved in 44 markets as BeiGene continues to advance its global registration, including the EU, US, and Great Britain